Clinical Trial: Is Detoxification Needed in Medication-overuse Headache?

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Is Detoxification Needed in Medication-overuse Headache?: A Randomized Controlled Trial of 3 Treatment Strategies

Brief Summary:

Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to European guidelines and based on evidence, multidisciplinary detoxification is the first choice of treatment for MOH. However, consensus about the details in such detoxification programs is lacking. Contrary, other headache specialists believe more in treating chronic headache with medication overuse with single-therapy of prophylaxis and no withdrawal of acute medication, based on randomized controlled double-blinded placebo trial with prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to detoxification. However there was no significant difference.

AIM:

  1. To compare three different treatment protocols in order to improve the therapy of MOH.
  2. To test several baseline variables for being potential predictors for good treatment outcome.
  3. To examine the role of epigenetics in MOH.

Detailed Summary:
Sponsor: Danish Headache Center

Current Primary Outcome:

  • Reduction in headache days per month in group A and C compared to group B. [ Time Frame: Six months follow-up ]
  • Number Needed to Treat based on cured medication-overuse headache in group A and C compared to group B. [ Time Frame: Six months follow-up ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction in headache days per month [ Time Frame: Two and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Number Needed to Treat based on cured medication-overuse headache [ Time Frame: Two and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Reduction in days/month with use of analgesics and/or migraine medication. [ Time Frame: Two, 6 and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%). [ Time Frame: Two, 6 and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Reduction in headache intensity. [ Time Frame: Two, 6 and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).

    This outcome will be presented as 1) Total headache intensity per month, and as 2) Visual Analogue Scale (VAS).

  • Descriptive report of self-reported adverse effects of treatments. [ Time Frame: Two, 6 and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Changes in Headache Under-Response to Treatment (HURT)-score. [ Time Frame: Two, 6 and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Drop-out rate. [ Time Frame: One, 2, 4, 6, 9 and 12 months follow-up ]
  • Changes in Hospital Anxiety and Depression Scale (HADS). [ Time Frame: Six and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Changes in Quality of Life (QoL) score. [ Time Frame: Six and 12 months follow-up ]
    1. Group A and C versus group B.
    2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
  • Changes in Severity of Dependence Score (SDS). [ Time Frame: Six and 12 months follow-up ]
    2. Reduction in headache days per month [ Time Frame: Two and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    3. Number Needed to Treat based on cured medication-overuse headache [ Time Frame: Two and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    4. Reduction in use of analgesics and/or migraine medication. [ Time Frame: Two, 6 and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    5. Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%). [ Time Frame: Two, 6 and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    6. Reduction in headache intensity. [ Time Frame: Two, 6 and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    7. Adverse effects of treatments. [ Time Frame: Two, 6 and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    8. Changes in Headache Under-Response to Treatment (HURT)-score. [ Time Frame: Two, 6 and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    9. Drop-out rate. [ Time Frame: One, 2, 4, 6, 9 and 12 months follow-up ]
    10. Changes in Hospital Anxiety and Depression Scale (HADS). [ Time Frame: Six and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    11. Changes in Quality of Life (QoL) score. [ Time Frame: Six and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).
      3. Group B (single-therapy with prophylaxis) versus group C (detoxification with postponed prophylaxis).
    12. Changes in Severity of Dependence Score (SDS). [ Time Frame: Six and 12 months follow-up ]
      1. Group A and C versus group B.
      2. Group A (detoxification with prophylaxis) versus group C (detoxification with postponed prophylaxis).