Trial Outcomes & Findings for Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children (NCT NCT03447782)

Last Updated: 2022-05-06

Results Overview

1\. A change in pain intensity scores and headache frequency from visit 1 (V1) compared to visit 4 (V4) for NDPH patients after naltrexone has been administered for approximately 3 months. The NRS (numerical rating scale) will be used, with a pain score between 0 to 10, with 0 being no pain and 10 being worst pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

3 months

Results posted on

2022-05-06

Participant Flow

No healthy controls were able to be recruited as the COVID-19 pandemic caused the study to shut down.

Participant milestones

Participant milestones
Measure	NDPH Persistent Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally). Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone. Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder
Overall Study STARTED	45
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endogenous Modulation and Central Sensitization in New Daily Persistent Headache ( NDPH ) in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NDPH Persistent n=45 Participants Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally). Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone. Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder
Age, Categorical <=18 years	45 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.7 years STANDARD_DEVIATION 1.32 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	36 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Native American or Alaskan Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	7 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The healthy control arm was not included here because COVID-19 necessitated the shut-down of this protocol and no healthy controls were able to be recruited.

Outcome measures

Outcome measures
Measure	NDPH Persistent n=25 Participants Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally). Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone. Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder
Pain Intensity V1 Pain Rating	5.82 score on a scale Standard Deviation 1.47
Pain Intensity V4 Pain Rating	4.92 score on a scale Standard Deviation 1.64

SECONDARY outcome

Timeframe: 3 months

Population: The healthy control arm was not included here because COVID-19 necessitated the shut-down of this protocol and no healthy controls were able to be recruited.

1\. A change in functional disability scores - The functional disability inventory (FDI) will be used to assess differences in disability pre- and post-naltrexone treatment for NDPH patients The FDI is a valid and reliable measure consisting of 15 items concerning perceptions of physical and psychosocial function. Total scores range from 0 to 60, with higher scores indicating greater disability.

Outcome measures

Outcome measures
Measure	NDPH Persistent n=25 Participants Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally). Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone. Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder
Functional Disability FDI V1	15.16 score on a scale Standard Deviation 8.56
Functional Disability FDI V4	10.96 score on a scale Standard Deviation 8.46

SECONDARY outcome

Timeframe: 3 months

Population: The healthy control arm was not included here because COVID-19 necessitated the shut-down of this protocol and no healthy controls were able to be recruited.

A change in self-perceived pain sensitivity - The Pain Sensitivity Questionnaire (PSQ) will be used to assess differences in pain sensitivity pre- and post-naltrexone treatment, as well as between persistent patients and healthy controls. The Pain Sensitivity Questionnaire (PSQ) PSQ is a valid 17 item self-report measure of pain sensitivity. Each item is rated on a scale of 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The PSQ will be used to assess differences in pain sensitivity pre- and post-naltrexone treatment, as well as between recovered and persistent patients.

Outcome measures

Outcome measures
Measure	NDPH Persistent n=25 Participants Patients will be evaluated in clinic 1 month after the phone call evaluation. At this time, patients will begin a 3 month trial of low-dose naltrexone (Naltrexone HCL powder compounded to provide 4.5mg once per day orally). Patients will be evaluated in clinic 3 months after beginning treatment with naltrexone. Naltrexone HCl (Bulk) Powder: For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder
Self- Perceived Pain Sensitivity PSQ total V1	3.21 units on a scale Standard Deviation 1.03
Self- Perceived Pain Sensitivity PSQ total V4	3.22 units on a scale Standard Deviation 1.50

Adverse Events

NDPH Persistent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alyssa Lebel

Boston Children's Hospital

Phone: 7812161960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place