The Childhood and Adolescent Migraine Prevention Study (CHAMP)
|ClinicalTrials.gov Identifier: NCT01581281|
Recruitment Status : Terminated (Interim assessment provided sufficient data to answer study questions)
First Posted : April 20, 2012
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Migraine Migraine Disorders Headache||Drug: Amitriptyline Drug: Topiramate Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Amitriptyline and Topiramate in the Prevention of Childhood Migraine|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||January 2016|
Active Comparator: Amitriptyline
Drug to be administered twice daily.
Amitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based.
Active Comparator: Topiramate
Drug to be administered twice daily.
Topiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based.
Placebo Comparator: Placebo
To be administered twice daily.
Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.
- Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days [ Time Frame: 4 week baseline period and last 4 weeks of the 24-week trial ]
The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight.
For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups.
- Change in Absolute Headache Disability Score on PedMIDAS [ Time Frame: baseline and 24 week endpoint ]
The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for:
- Amitriptyline vs. Placebo
- Topiramate vs. Placebo
- Amitriptyline vs Topiramate
- Change in Number of Headache Days [ Time Frame: 4 week baseline period and last 4 weeks of the 24-week trial ]
This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between:
- Amitriptyline vs. placebo
- Topiramate vs. placebo
- Amitriptyline vs. Topiramate
- Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase [ Time Frame: 24 weeks ]To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups.
- Occurrence of Treatment Emergent Serious Adverse Events [ Time Frame: 24 weeks of the trial ]To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581281
Show 35 Study Locations
|Principal Investigator:||Scott W. Powers, PhD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Andrew D. Hershey, MD, PhD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Christopher S. Coffey, PhD||The University of Iowa|