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Trial record 1 of 1 for:    Amitriptyline in the Prevention of Childhood Migraine
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The Childhood and Adolescent Migraine Prevention Study (CHAMP)

This study has been terminated.
(Interim assessment provided sufficient data to answer study questions)
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01581281
First received: December 16, 2011
Last updated: July 11, 2017
Last verified: July 2017
Results First Received: November 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Migraine
Migraine Disorders
Headache
Interventions: Drug: Amitriptyline
Drug: Topiramate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From July 16, 2012 through November 24, 2014, 488 patients were assessed for eligibility from 31 sites in the United States. Of those, 361 patients underwent randomization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the patients assessed for eligibility, 21 (4%) did not undergo randomization owing to early trial closure and 106 (22%) were excluded. Eighty-one (81) were excluded due to not meeting inclusion criteria, 25 declined participation (13 were unwilling, but eligibility was otherwise confirmed and 12 were willing and eligibility was unknown).

Reporting Groups
  Description
Topiramate Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
Placebo Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
Amitriptyline Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.

Participant Flow:   Overall Study
    Topiramate   Placebo   Amitriptyline
STARTED   145   72   144 
COMPLETED   130   66   132 
NOT COMPLETED   15   6   12 
Early Study Closure                15                6                12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Topiramate Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
Placebo Placebo enclosed in capsules to maintain the blind was administered orally twice daily during an 8 week titration period followed by a 16 week maintenance phase (mirroring the other two treatment arms).
Amitriptyline Amitriptyline enclosed in capsules to maintain the blind was administered orally in dose of 1 capsule twice daily (AM capsule did not contain medication. A target dose was 1 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.
Total Total of all reporting groups

Baseline Measures
   Topiramate   Placebo   Amitriptyline   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   72   144   361 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      145 100.0%      72 100.0%      144 100.0%      361 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.2  (2.5)   14.2  (2.2)   14.2  (2.4)   14.2  (2.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      101  69.7%      49  68.1%      97  67.4%      247  68.4% 
Male      44  30.3%      23  31.9%      47  32.6%      114  31.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      14   9.7%      6   8.3%      8   5.6%      28   7.8% 
Not Hispanic or Latino      123  84.8%      65  90.3%      128  88.9%      316  87.5% 
Unknown or Not Reported      8   5.5%      1   1.4%      8   5.6%      17   4.7% 
Race (NIH/OMB) [1] [2] 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      14   9.7%      5   6.9%      8   5.6%      27   7.5% 
Asian      6   4.1%      0   0.0%      0   0.0%      6   1.7% 
Native Hawaiian or Other Pacific Islander      1   0.7%      0   0.0%      0   0.0%      1   0.3% 
Black or African American      24  16.6%      17  23.6%      26  18.1%      67  18.6% 
White      98  67.6%      48  66.7%      107  74.3%      253  70.1% 
More than one race   NA [1]   NA [1]   NA [1]   NA [2] 
Unknown or Not Reported      2   1.4%      2   2.8%      3   2.1%      7   1.9% 
[1] data not collected
[2] Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   145   72   144   361 
Headache Days [1] 
[Units: Days]
Mean (Standard Deviation)
 11.5  (6.1)   11.0  (6.3)   11.5  (6.2)   11.4  (6.1) 
[1] Number of headache days during 28-day baseline period
Pediatric Migriane Disability Assessment Score (PedMIDAS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 42.6  (27.4)   42.9  (26.7)   40.6  (26.4)   41.9  (26.8) 
[1] Scores on the PedMIDAS range from 0 to 240, with a score of 1 to 10 indicating no disability, 11 to 30 indicating mild disability, 31 to 50 indicating moderate disability, and more than 50 indicating severe disability.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Change in Absolute Headache Disability Score on PedMIDAS   [ Time Frame: baseline and 24 week endpoint ]

3.  Secondary:   Change in Number of Headache Days   [ Time Frame: 4 week baseline period and last 4 weeks of the 24-week trial ]

4.  Secondary:   Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase   [ Time Frame: 24 weeks ]

5.  Secondary:   Occurrence of Treatment Emergent Serious Adverse Events   [ Time Frame: 24 weeks of the trial ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott Powers, PhD
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-8106
e-mail: scott.powers@cchmc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01581281     History of Changes
Other Study ID Numbers: CIN-001
1U01NS076788-01 ( U.S. NIH Grant/Contract )
Study First Received: December 16, 2011
Results First Received: November 16, 2016
Last Updated: July 11, 2017