Trial Outcomes & Findings for Therapeutic Effect of Desogestrel on Ventilatory Control in Patients With Congenital Central Hypoventilation Syndrome (NCT NCT01500473)

Results Overview

Increase in minute ventilation as oxygen saturation of hemoglobin falls.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

3 weeks

Results posted on

2023-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Females With CCHS > 16 Years Old on Desogetrel open label studied on drug. Desogestrel: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapeutic Effect of Desogestrel on Ventilatory Control in Patients With Congenital Central Hypoventilation Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Females With CCHS > 16 Years Old on Desogetrel n=1 Participants open label studied on drug. Desogestrel: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel
Age, Categorical <=18 years	1 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
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Increase in minute ventilation as oxygen saturation of hemoglobin falls.

Outcome measures

Outcome measures
Measure	Females With CCHS > 16 Years Old on Desogetrel n=1 Participants open label studied on drug. Desogestrel: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel
Hypoxic Ventilatory Response	0 subjects with positive response

PRIMARY outcome

Timeframe: 3 weeks

Increase in ventilation with increasing partial pressure of CO2

Outcome measures

Outcome measures
Measure	Females With CCHS > 16 Years Old on Desogetrel n=1 Participants open label studied on drug. Desogestrel: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel
Hypercapnic Ventilatory Response	-0.520 liters per minute/ mmHg PCO2

PRIMARY outcome

Timeframe: 3 weeks

length of time the subject could breathe adequately spontaneously until SpO2 fell below 80% and or PetCO2 rose above 65 mmHg.

Outcome measures

Outcome measures
Measure	Females With CCHS > 16 Years Old on Desogetrel n=1 Participants open label studied on drug. Desogestrel: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel
Time Maintained Ventilation Off Mechanical Ventilation During Sleep.	89 seconds

Adverse Events

Females With CCHS > 16 Years Old on Desogetrel

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

Thomas Keens

Children's Hospital Los Angeles

Phone: 3233612101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place